Laboratory Info System Application Specialist

Job Description

Laboratory Info System Application Specialist

Location: Exton PA

Full-time, On-site

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position Summary:

The Laboratory Information System (LIS) Application Specialist will be responsible for implementation and maintenance of the Central Laboratory Information System, instrument middleware, and other supporting software systems for Central Lab Services.

Responsibilities:

Build and maintain LIS/LIMS database for clinical trial and medical diagnostic testing and Biorepository

Assist laboratory management and QA Specialist with comprehensive Change Control related to the Laboratory Information Systems.

Liaise between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts

Partner with Study Setup and Project Management to build appropriate tests and calculations

Working with Senior System Administrator to develop and maintain Central Lab Service procedures regarding LIS/LIMS, middleware, and other supporting software systems

Ensure HIPAA and GDPR compliance in Central Lab Services processes in conjunction with QA and laboratory management.

Requirements:

B.A/B.S. in Biology, chemistry, or related scientific disciplines with experience in a clinical laboratory setting

Minimum of 1 years’ experience in test build

Experience with LabVantage

Experience in performing or assisting clinical laboratory testing

Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desirable

High level of accountability with self and others

Hands-on approach with a desire to teach others

Track record of challenging the status quo

Team and action-oriented

Problem-solving

Priority setting

Timely decisions

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

Full-time